Goto Main Content
:::

Chapter Law Content

Title: Drug Injury Relief Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter III Services for Drug Injury Relief
Article 9
Drug manufacturers and importers shall, according to the deadline specified by the competent authority, declare the information and relevant documents related to estimated sales number for current year or sales number from previous year.
In order to provide drug injury relief and relevant services, the competent authority may request drug manufacturers and importers to provide relevant documents, and the drug manufacturers and importers shall not refuse, avoid or impede.
Article 10
In order to provide drug injury relief and relevant services, the competent authority may request tax authority, medical institutions and other authority (institution) or organization to provide relevant documents, and the requested party shall not refuse, avoid or impede.
Article 11
The staff or personnel who are in charge of the drug injury relief set forth in this Act, shall not disclose any confidential information of drug manufacturers, importers or drug injury victims whom is aware of and in possession of as a result from services providing, and the staff shall not take advantage on the information for its own profits.
Article 12
The eligible applicants of drug injury relief are as follow:
1. Death payment: heirs of the victim.
2. Disable payment or severe illness payment: victim himself/herself or his/her statutory agent.
The competent authority shall establish the regulation for application procedure of the applicants set forth in preceding Paragraph, required documents and other obligations.
Article 13
Person who has the conditions below is not eligible for any drug injury relief:
1. The fact shows the drug injury is the responsibility of the drug injury victim, drug manufacturer or importer, physician or others.
2. The discovery of the drug injury occurred before the implementation of this Act.
3. The injury resulting from vaccination and being eligible to apply for the relief under other laws and regulations..
4. The compensation or indemnification having received for the same basis and fact, except for the payment for personal insurance.
5. Adverse reactions resulting from drug usage does not meet the level of death, disability or severe illness.
6. The injury from drug overdose under the emergency medical care.
7. The injury from using investigational drugs.
8. The injury from off-indication use, which means not following the indications or utility stated on the drug permit; Unless the use is complied with current medical practice and medication appropriateness.
9. The common and foreseeable adverse reaction from drug usage.
10. Other condition promulgated by the competent authority.
Article 14
The claim with regard to the drug injury relief is extinguished by prescription if not exercised within three years from the date when the applicant became known to the drug injury.
Article 15
The competent authority shall establish the Drug Injury Relief Review Committee (hereinafter referred to as “the Review Committee”) in charge of the application approval and the amount determination; the regulations for the committee organization and the reviewing procedure shall be established by the competent authority.
The Review Committee set forth in preceding Paragraph is composed of eleven to seventeen committee members, where comes from medical, pharmaceutical, legal experts and impartial social representatives and appoints by the competent authority. At least one third of the members shall come from legal experts and impartial social representatives.
Article 16
The Review Committee shall make a determination within three months after receiving an application of drug injury relief; the three months period may be extended if necessary. The extension period shall be less than a month.
Article 17
Person who has received the Drug Injury Relief Payment and also received other compensation or indemnification based on the same fact and reason, shall return the received payment within the scope of the amount that he/she has been compensated or indemnified.
Article 18
The competent authority may enforce its subrogation right within the scope of the amount which has been paid, if it discovers any party shall be liable for the drug injury after the payment.
Article 19
The right for drug injury relief shall not be transferred, offset, seized or guaranteed.
The payment of drug injury relief is exempt from personal income tax; the right to receive the payment is exempted from inheritance tax.